ReviStim REVSTM2
ReviStim REVSTM2 is a medical device (FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter) made by Prizm Medical, Inc., cleared under FDA 510(k) K033122 on 25 Aug 2004 and listed in FDA GUDID since 7 May 2020 (UDI-DI B872REVSTM20), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB872REVSTM20 | Date7 May 2020 | StatusListed |
| United States | FDA 510(k)SESU | NumberK033122 | Date25 Aug 2004 | StatusActive |
Official records
- FDA 510(k) database K033122
Across registries
- FDA 510(k) K033122 decided 25 Aug 2004 Active
- FDA GUDID UDI-DI B872REVSTM20 listed 7 May 2020 Listed
Timeline
- Cleared FDA 510(k) K033122
- Listed FDA GUDID B872REVSTM20
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ReviStim
- Generic name
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Model / reference
- REVSTM2
- Primary DI / UDI-DI
- B872REVSTM20
- 510(k) Number
- FDA product code
- NUH
- GMDN term
- Physical therapy transcutaneous neuromuscular electrical stimulation system
- Device class
- Class II
- Regulation number
- 882.5890
- GUDID distribution status
- In Commercial Distribution
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